MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC RPS PLATE 8 HOLE 50MM DARCO SYSTEM STERILE; PLATE, FIXATION, BONE

Catalog Number	DCS2803008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device(s) were not returned for evaluation, and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
Event or Problem Description
The manufacturer received scs study named "a retrospective data collection of the treatment of small bones of the feet, ankles and toes with the darco¿ modular rearfoot system (mrs)" that contains collected data on the usage and the outcomes of darco¿ modular rearfoot system (mrs).The report details analysis provided for procedures performed between (b)(6) 2016 - (b)(6) 2018.During the review of the report, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available; however, the following adverse event was reported: one fracture fixation patient with an 8-hole rps plate was determined to be a radiographic nonunion.

• Brand Name: RPS PLATE 8 HOLE 50MM DARCO SYSTEM STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23602732
• Report Number: 3010667733-2025-01375
• Device Sequence Number: 18456350
• Product Code: HRS
• UDI-Device Identifier: 00840420111876
• UDI-Public: 00840420111876
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DCS2803008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown